Quick SARS-CoV-2 rRT-PCR Kit

R3011 / R3011-1K / R3011-10K


Quick SARS-CoV-2 rRT-PCR Kit

Cat # Name Size
R3011 Quick SARS-CoV-2 rRT-PCR Kit 100 rxns
R3011-1K Quick SARS-CoV-2 rRT-PCR Kit 1,000 rxns
R3011-10K Quick SARS-CoV-2 rRT-PCR Kit 10,000 rxns
Documents

Instructions for Use: 
Patient Fact Sheet: 
Healthcare Provider Fact Sheet: 
KingFisher Script: 
Quick SARS-CoV-2 rRT-PCR Kit

Highlights

  • Approved for emergency use authorization (EUA) by the U.S. Food and Drug Administration and CE-IVD certified.
  • High Sensitivity: Limit of Detection as low as 15 copies/reaction.
  • Specific: Detection of SARS-CoV-2 and Emerging Strains
  • Rapid & Easy Setup: Ready-to-use Master Mix, just add sample.
  • Compatible with Automated and High-Throughput workflows.
Description

The Quick SARS-CoV-2 rRT-PCR Kit is a real-time reverse transcription PCR (rRT-PCR) test for the qualitative detection of RNA from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which is responsible for the coronavirus disease (COVID-19).

The Quick SARS-CoV-2 rRT-PCR Kit targets three different regions of the viral nucleocapsid (N) gene and a host-specific target region (human RNase P gene) to assess sample quality. The kit also includes CV Positive Control that enable assay performance monitoring, and a No-Template Control to confirm the absence of contamination in the reagents.

The Quick SARS-CoV-2 rRT-PCR Kit can be used on purified RNA samples isolated from upper respiratory and lower respiratory systems.

The Quick SARS-CoV-2 rRT-PCR Kit has High Sensitivity, with a Limit of Detection as low as 15 viral genome equivalent copies per reaction, a fast turnaround time of less than 1.5 hours, and a simple workflow in which RNA is simply added to the Quick SARS-CoV-2 rRT-PCR Kit reagents and directly analyzed.

Due to its simplicity, set-up up can be performed in an automation and it is compatible with high-throughput platforms. The kit is compatible with multiple Real-Time PCR instruments and technical support is available for all steps of the setup process and data interpretation.

Learn More

In the United States:

-This test has not been FDA cleared or approved;
-This test has been authorized by FDA under an EUA for use by authrized laboratories;
-This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
-This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner

Qualitative assay for use on the Bio-Rad CFX96 Real-Time PCR Detection System. For use under the FDA Emergency Use Authorization (EUA) only. For in vitro diagnostic use.


This kit is for use with DNA/RNA Shield collection devices for sample collection, and the Quick-DNA/RNA Viral MagBead Kit for sample processing under Emergency Use Authorization.

The end-to-end EUA authorized workflow consists of sample collection, sample preparation, and real-time RT-PCR analysis.

Authorized laboratories using the Quick SARS-CoV-2 rRT-PCR Kit must run the assay as outlined in the Instructions for Use. Deviations from the FDA authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to perform the Quick SARS-CoV-2 rRT-PCR Kit are not permitted.


Cat # Name Size Price